Resilient Families Program for Parenting
(R-FAM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help parents with babies in the Neonatal Intensive Care Unit (NICU) manage emotional stress and improve their relationships. The study will develop and test a program called Resilient Families (R-FAM), designed to support parents during this challenging time. Researchers will compare the program's effectiveness against standard care to determine its true benefits. Parents with a baby in the NICU who feel stressed, are in a relationship, and plan to live with the baby after the NICU may be a good fit for this trial. As an unphased trial, this study offers a unique opportunity for parents to contribute to research that could significantly enhance support systems for families in the NICU.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Resilient Families Program is safe for parents in the NICU?
Research has shown that the Resilient Families (R-FAM) program aims to help families enhance their well-being and relationships, particularly under stress. Although specific safety data from clinical trials is unavailable, the community-based approach has generally yielded positive results. The program incorporates mindfulness and trauma-informed practices, which participants typically find manageable. It is important to note that this trial is in the "Not Applicable" phase, focusing on developing and testing the program's effectiveness rather than assessing safety, as drug trials do. This indicates that the program is considered low-risk.12345
Why are researchers excited about this trial?
The Resilient Families (R-FAM) program is unique because it focuses on a dyadic resiliency intervention, which is a fresh approach compared to traditional parenting support programs that often focus solely on individual or group therapy. Traditional options might include parenting classes or therapy sessions that don't necessarily address the dynamic between parent and child directly. Researchers are excited about this program because it targets the parent-child relationship directly, aiming to build resilience in both parties simultaneously. This method could potentially strengthen family connections more effectively and quickly than existing methods, offering a holistic approach to enhancing family resilience.
What evidence suggests that the Resilient Families program is effective for reducing emotional distress and improving relationships among NICU parents?
Research has shown that family resilience programs can enhance emotional well-being and relationships. Increased family resilience often leads to a better quality of life and reduced stress for both parents and children. One study found that family resilience helps parents manage stress more effectively, particularly in challenging situations like the NICU. These findings suggest that the Resilient Families (R-FAM) program, offered in this trial as a dyadic resiliency intervention, might reduce emotional distress and improve relationships among parents in the NICU by building resilience.678910
Are You a Good Fit for This Trial?
This trial is for adult parents or legal guardians (and their partners) of a baby in the NICU. They must be over 18, in an intimate relationship, planning to live with the baby after discharge, and at least one partner should be emotionally distressed. Participants need to speak English and join via live video.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention Development
Develop R-FAM using stakeholder input from interviews with parent dyads and focus groups with NICU staff
Pilot Optimization
Optimize R-FAM through an open pilot with pre/post assessments and exit interviews
Treatment
Participants receive the dyadic resiliency intervention (R-FAM) for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Resilient Families (R-FAM)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor